NCATS Eyes Changes to CTSA as Sequestration Limits Options

NIH says it will improve its Clinical and Translational Science Awards (CTSA) program by strengthening its leadership, standardizing the evaluation of centers, increasing collaboration, ramping up its engagement with patient groups, and enhancing its transparency—based on recommendations made yesterday by the Institute of Medicine (IOM).

But the NIH official whose center oversees CTSA acknowledged that implementing IOM’s recommendations will be hampered by continuing across-the-board federal budget cuts or “sequestration” that may ultimately shrink the program.

Christopher P. Austin, M.D., director of the National Center for Advancing Translational Sciences (NCATS), said NIH will convene a working group of NCATS advisory board members and others to advise him on implementing IOM’s recommendations swiftly.

Dr. Austin said NCATS will step up involvement in CTSA, setting goals and objectives as well as establishing a new working group of key stakeholders to advise on implementation of the report’s recommendations. The report also suggested CTSA promote collaborations beyond those of its 61 centers, such as with other institutions, patient groups, healthcare providers, the biopharma industry, and government agencies.

Engagement of patients, plus family members, should help CTSA carry out another IOM recommendation: Strengthening clinical and translational research related to child health.

“These things are absolutely critical to the success of the program, because the success of the program is going to be dependent on transforming the clinical and translational research ecosystem,” Dr. Austin said during a phone conference with reporters.

“This fund could be created through a set-aside mechanism within the CTSA Program that provides flexible funding to foster collaborative efforts that are pioneering and have great potential to accelerate clinical and translational research. Projects associated with this fund should include clear metrics and evaluation measures,” the report stated.

The report did not spell out what those measures should be, and shied away from one possible answer.

“Although it would be ideal to evaluate the CTSA Program’s impact on clinical care and public health, currently this is neither feasible nor realistic given the numerous driving forces that shape the research enterprise and the multitude of factors that affect health outcomes," it stated.

No ‘Magic Wand’

CTSA’s 61 centers are funded through five-year agreements, with site budgets ranging from $4 million to $23 million annually. The program’s total budget was $461 million in FY 2012.

IOM offered a mostly positive assessment of CTSA, concluding that the program “is contributing significantly to the advancement of clinical and translational research and is therefore a worthwhile investment that would benefit from a variety of revisions to make it more efficient and effective.”

Those revisions, Dr. Austin added, will emerge under the expectation of at least flat, if not shrinking, budgets due to sequestration. “We’re trying to figure out which of those agenda items we can do with minimal or no new investment," he said.

Asked by GEN whether CTSA can continue sustaining 61 centers or would have to shrink as a result, Dr. Austin replied: “Ultimately, the program is going to have to be right-sized to fit the budget that we now have. That will be done on the basis of scientific peer review and programmatic priorities. But there’s no doubt that the sequester has already had and will continue to have a substantial impact on our ability to do the science that the public expects and deserves, and that the science can deliver."

“I wish I had a magic wand. If I was [U.S. Federal Reserve Chairman] Ben Bernanke, I could print the money,” he quipped.

“Unfortunately, we are in the same boat that everyone else at NIH is.”

This article has been updated to clairfy NCATS will establish a working group to advise on implementation of recommendations made by IOM.